A Safety, Tolerability and Efficacy Study of E7070 in Patients With Renal Cell Carcinoma

This study has been completed.
Sponsor:
Information provided by:
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT00059735
First received: May 5, 2003
Last updated: February 29, 2008
Last verified: February 2008
  Purpose

The purpose of this study is to determine if E7070 is a safe and effective treatment for cancer of the kidneys.


Condition Intervention Phase
Kidney Neoplasms
Carcinoma, Renal Cell
Adenocarcinoma, Renal Cell
Drug: E7070
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of E7070 in Patients With Progressive Inoperable and/or Metastatic Renal Cell Carcinoma (RCC)

Resource links provided by NLM:


Further study details as provided by Eisai Inc.:

Enrollment: 30
Study Start Date: May 2002
Study Completion Date: December 2003
Detailed Description:

Renal Cell Carcinoma (RCC) accounts for approximately 2% of all cancers and its incidence is increasing with worldwide deaths of over 100,000 patients per year. About 50% of RCC patients have inoperable or metastatic disease that surgery cannot be performed on. RCC is also considered to be resistant to both radiotherapy and cytotoxic chemotherapy. The purpose of this study is to evaluate the safety and effectiveness of E7070 by assessing progression free survival, tumor response rate, duration of response/stable disease, and survival time. E7070 will be administered as a single iv infusion over 60 minutes on Day 1 of each cycle. Patients will continue treatment with E7070 until they no longer have clinical benefit and have disease progression, or toxicity leads to patient withdrawal.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age >=18 years old.
  • Have histologically/cytologically confirmed clear cell RCC.
  • Previously untreated or one prior treatment with immunotherapy (one prior treatment may be represented by single agent interferon, single agent interleukin-2 or a combination of interferon with interleukin-2 with or without accompanying hematological growth factors).
  • Documented evidence of progressive disease in the previous 3 months. In the absence of radiographic studies, patients may be entered on the study if they have clinical evidence of progressive disease.
  • Have at least one unidimensional measurable lesion of RCC according to the RECIST guidelines. The following will not qualify as measurable lesions: bone, leptomeningeal disease, ascites, pleural/pericardial effusion, lymphangitis cutis/pulmonis, abdominal masses that are not confirmed and followed by imaging techniques, and cystic lesions.
  • Be ambulatory and have a Karnofsky performance status >=70%.
  • Have a life expectancy of at least 3 months.
  • Give written informed consent prior to any study-specific screening procedures, with the understanding that the consent may be withdrawn by the patient at any time without prejudice.
  • Be willing and able to comply with the study protocol for the duration of the study.

Exclusion Criteria:

  • Woman who are pregnant or breastfeeding. Women of childbearing potential with either a positive pregnancy test at screening or no pregnancy test. Women of childbearing potential unless (1) surgically sterile or (2) using adequate contraceptive measures (postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential).
  • Fertile male subjects not willing to use contraception and whose female partners are not under adequate contraceptive protection.
  • Known CNS metastases (if clinical suspicion of CNS metastases exists appropriate imaging must be performed prior to study entry).
  • Prior treatment with chemotherapy (there is no restriction on prior epidermal growth factor directed therapy).
  • Severe and uncontrolled cardiac or cardiovascular abnormalities.
  • Severe uncontrolled intercurrent infections.
  • Subjects with organ allografts.
  • Any of the following abnormal screening hematological values: Hemoglobin (Hb) <9g /dL (6 mmol/L), Neutrophils <1.5 x 10^9/L, Platelets <100 x 10^9/L.
  • Blood transfusions or growth factors to aid hematological recovery within 2 weeks prior to starting study treatment.
  • Any of the following abnormal screening liver function tests: serum bilirubin >= 1.5 x upper normal limit (ULN), alanine aminotransferase (ALAT) and aspartate aminotransferase (ASAT) >= 2.5 x ULN (unless related to liver metastases in which case >= 5 x ULN).
  • The following abnormal screening renal function tests: either a serum creatinine > 1.5 x ULN or a creatinine clearance (estimated from serum creatinine) < 40 mL/minute.
  • Prior radiotherapy (except palliative).
  • Participation in any investigational drug study or immunotherapy within 4 weeks preceding treatment start.
  • History of hypersensitivity to sulphonamides.
  • Any concurrent or previous malignancy of a different tumor type within 5 years of starting E7070 treatment except for adequately treated non-melanoma skin cancer or cervical intra-epithelial neoplasia.
  • Significant disease, which in the Investigator's opinion would exclude the patient from the study.
  • Surgically resectable metastatic disease.
  • Legal incapacity.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00059735

Locations
United States, California
Sacramento, California, United States, 95817
United States, New York
Bronx, New York, United States, 10466
New York, New York, United States, 10021
New York, New York, United States, 10032
France
Villejuif Cedex, France, 94805
Sponsors and Collaborators
Eisai Inc.
Investigators
Study Director: Murray Yule, MRCP, PhD Eisai Limited
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00059735     History of Changes
Other Study ID Numbers: E7070-A001-206
Study First Received: May 5, 2003
Last Updated: February 29, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Eisai Inc.:
kidney cancer
kidney neoplasms
renal cell cancer

Additional relevant MeSH terms:
Adenocarcinoma
Neoplasms
Carcinoma
Carcinoma, Renal Cell
Kidney Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on July 28, 2014